IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today issued the following statement in response to the national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR) released by the Centers for Medicare & Medicaid Services (CMS):“Edwards is pleased that this updated policy represents an important step toward improving and expanding patient access to TAVR while reinforcing the value of a multidisciplinary Heart Team. Aortic stenosis is a serious, pro
Tag: TAVR
Emboline Receives U.S. FDA 510(k) Clearance for Emboliner® Embolic Protection System
Clearance brings full cerebral and systemic embolic protection to patients undergoing transcatheter aortic valve replacement (TAVR) SANTA CRUZ, Calif., Sept. 9, 2026 /PRNewswire/ — Emboline, Inc., a medical technology company developing next-generation embolic protection technology,…
Medtronic Announces Strategic Investment in Pi-Cardia to Accelerate Innovation for Complex TAVR
GALWAY, Ireland and REHOVOT, Israel, Sept. 1, 2026 /PRNewswire/ — Medtronic plc (NYSE: MDT), a global leader in healthcare technology, and Pi-Cardia Ltd., a pioneer in leaflet modification technologies for structural heart disease, today announced a strategic investment by Medtronic in…
Venus Medtech Announces Completion of Patient Enrollment in Pivotal China Trial for Venus-PowerX, the World’s First Fully Recoverable Self-Expanding Dry-Valve TAVR System
The PREVAILS study, now fully enrolled, marks a critical step toward simultaneous regulatory submissions in China and Europe for the next-generation TAVR system HANGZHOU, China, July 23, 2026 /PRNewswire/ — Venus Medtech (Hangzhou) Inc. (02500.HK) today announced that patient enrollment…
TAVR Changed Valve Replacement; Anteris Says Longer-Living Patients Expose the Next Challenge
As transcatheter aortic valve replacement (TAVR) expands into patients who may live decades after treatment, the structural heart industry is being forced to confront what its first generation of valves was not built to answer: what happens when the patient outlives the implant?…
EmStop™ Announces Initiation of CAPTURE-2 IDE Clinical Trial
The trial will generate critical clinical evidence and discovery for the novel medical device. MINNEAPOLIS, May 18, 2026 /PRNewswire/ — EmStop, Inc., a cardiovascular medical device company, announced the initiation of the CAPTURE-2 Investigational Device Exemption (IDE) clinical trial…
MiRus Siegel™ TAVR: First EFS Cases
ATLANTA, March 28, 2025 /PRNewswire/ — MiRus is pleased to announce the launch of the US multi-center Early Feasibility Study of the Siegel™ 8-Fr aortic transcatheter heart valve (THV). The first two cases were successfully performed this week by Pradeep K. Yadav MD, Director of…
German Medtech Protembis Gets €20 Million EIB Backing for Technology to Protect Brain During Heart Treatment
July 30, 2024 01:00 AM Eastern Daylight Time LUXEMBOURG & AACHEN, Germany–(BUSINESS WIRE)–The European Investment Bank (EIB) is providing €20 million in venture-debt financing to German medical-technology company Protembis to develop a next-generation device for protecting the brains of patients who undergo certain heart treatments. “This agreement demonstrates our commitment […]
Edwards Launches the SAPIEN 3 Ultra RESILIA Valve in Europe With Technology to Enhance Durability
NYON, Switzerland–(BUSINESS WIRE)–Edwards Lifesciences today announced the European launch of the SAPIEN 3 Ultra RESILIA valve, the only transcatheter aortic heart valve to incorporate the company’s breakthrough RESILIA tissue technology, designed to extend the valve’s durability.* Edwards’ SAPIEN 3 Ultra RESILIA valve recently received CE Mark† for use in patients with […]
Medtronic announces FDA approval of newest-generation Evolut TAVR system for treatment of symptomatic severe aortic stenosis
The Evolut™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access DUBLIN, March 27, 2024 /PRNewswire/ — Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and…



